Ace Phenobarbital Reagent/Aed Calibrators
FDA 510(k) K973536 · Schiapparelli Biosystems, Inc.
510(k) numberK973536
Submission
- Device name
- Ace Phenobarbital Reagent/Aed Calibrators
- Applicant
- Schiapparelli Biosystems, Inc.
Fairfield, NJ, US - Received
- September 18, 1997
- Decision date
- November 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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More from Labone, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991733 | Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C ControlsMRR · Traditional | 07/13/1999SE |
| K981377 | Ace T4 Reagent T4 CalibratorsKLI · Traditional | 06/10/1998SE |
| K981375 | Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional | 06/10/1998SE |
| K973583 | Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional | 11/12/1997SE |
| K973582 | Ace Primidone Reagent, AED CalibratorsDJD · Traditional | 11/12/1997SE |
| K973581 | Ace Valproic Acid Reagent, AED CalibratorsLEG · Traditional | 11/12/1997SE |
| K973414 | Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional | 11/04/1997SE |
| K973535 | Ace Carbamazepine Reagent/Aed CalibratorsKLT · Traditional | 10/20/1997SE |
| K971526 | Ace Hdl-C ReagentLBS · Traditional | 05/21/1997SE |
| K954179 | HDL Precipitating ReagentLBR · Traditional | 12/11/1995SE |
Questions and answers
When was Ace Phenobarbital Reagent/Aed Calibrators cleared by the FDA?
Ace Phenobarbital Reagent/Aed Calibrators (K973536) received a 510(k) decision of Substantially Equivalent on November 6, 1997, 49 days after the submission was received.
What is the product code of K973536?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.